ZEROS Dental Implant System— 510(k) K260463
Substantially EquivalentZeros Co., Ltd.
FDA 510(k) clearance K260463 for ZEROS Dental Implant System, Substantially Equivalent on 2026-08-19. Applicant: Zeros Co., Ltd.. Device class: 2.
Summary
Zeros Co.'s ZEROS Dental Implant System is filed under product code DZE, root-form endosseous implants. The record gives no model numbers or sizes.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel, and it came in as a Special 510(k).
Zeros filed from Gyeongsangnam-Do, South Korea. The substantially equivalent decision came 188 calendar days after receipt (February 12 to August 19, 2026).
Clearance details
- Applicant
- Zeros Co., Ltd.
- Product code
- Product code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Gyeongsangnam-Do, KR
Recent devices under product code DZE
view allMore clearances from Zeros Co., Ltd.
view allAdverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.